Chunk #46 — PART II. CORE QUESTIONS — D. If Data and Samples Can Be Re-identified, Are There Any Biobank Research System Responsibilities to Offer Return of IFs and IRRs? — The ethics of return in biobank research systems
Secondary researchers accessing data and/or samples from the biobank will generally receive de-identified material that was not collected specifically for their research project and thus will be conducting research not covered by the Common Rule.13 This, combined with the fact that they will generally have no contact with contributors and may be far removed from data and sample collection in space and time, may lead some to conclude that secondary researchers have no responsibilities with respect to recognition of potentially returnable IFs or IRRs and their return. Yet this depicts secondary researchers in isolation rather than as part of the flow of data and samples through the biobank research system. Secondary researchers using biobank data or samples interact with the biobank. They apply for access to the data or samples, their application is reviewed and decided upon by the biobank’s Data Access Committee (DAC) or equivalent using explicit access criteria, negotiation may ensue over the terms of access, and access will be governed by an agreement, typically a Material Transfer Agreement (MTA) or Data Access Agreement (DAA) (sometimes called a
